Why it was recalled
Tablet Thickness: Product is being recalled due to the potential of being underweight or overweight.
Product description
Mefloquine HCL Tablets, 250 mg, 5 tablets per blister pack; 5 Blister packs per carton, Rx only, Teva Pharmaceuticals USA Sellersville, PA 18960, Individual blister pack: NDC 0555-0171-88, 25 Unit-Dose Tablets (5x5) Carton: NDC 0555-0171-78
Lot numbers, UPCs & expiration codes
Lot # 34000741A; Expiration date: 7/2013
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1396-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 2, 2012
- FDA report date
- Jul 4, 2012
- Quantity
- 4188 cartons (5 X 5 blisterpacks)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
Original FDA data
Every field from FDA enforcement report D-1396-2012, exactly as published.
Show all FDA fields
- City
- Sellersville
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 61664
- Address
- 650 Cathill Rd
- Code information
- Lot # 34000741A; Expiration date: 7/2013
- Postal code
- 18960-1512
- Report date
- Jul 4, 2012
- Product type
- Drugs
- Recall number
- D-1396-2012
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
- Product quantity
- 4188 cartons (5 X 5 blisterpacks)
- Termination date
- Mar 22, 2013
- Reason for recall
- Tablet Thickness: Product is being recalled due to the potential of being underweight or overweight.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Mefloquine HCL Tablets, 250 mg, 5 tablets per blister pack; 5 Blister packs per carton, Rx only, Teva Pharmaceuticals USA Sellersville, PA 18960, Individual blister pack: NDC 0555-0171-88, 25 Unit-Dose Tablets (5x5) Carton: NDC 0555-0171-78
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 2, 2012
- Initial firm notification
- Letter
- Center classification date
- Jun 26, 2012